Foldable Capsular Vitreous Body Implantation Study

NCT03390244 | Completed

• 1 other identifier: S59809
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to evaluate the clinical usefulness of the FCVB in its on-label use, but in a different racial type than studies till now (Asians only). The device will be inserted in Caucasian patients with permanent loss of functional vision (visual acuity hand movements or less), where a permanent use of repeat silicone oil is required to maintain the eye pressure.

Conditions

Vitreoretinal Surgery

Outcome Measures

Primary Outcomes (1)

• Intra-ocular pressure

  Evaluation of the device as long-term solution for maintenance the intra-ocular pressure, potentially reducing the number of surgeries (silicone oil exchanges) for the patient

  3 years

Study Arms (1)

FCVB Implant

EXPERIMENTAL

All subjects in this study are in the experimental treatment arm and will receive the FCVB implant

Device: Foldable Capsular Vitreous Body Implant

Interventions

Foldable Capsular Vitreous Body Implant DEVICE

Vitrectomy augmented with the implantation of the FCVB implant

FCVB Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged over 18
• Axial length between 16 and 28 mm (according the guidelines from the manufacturer)
• Loss of functional vision in study eye
• Visual acuity of 0.4 or better in fellow eye
• Requirement of (repeated) long-term silicone oil tamponade to maintain eye pressure and keep the retina attached

You may not qualify if:

• Visual acuity beyond 0.4 in non-study eye
• Severe general disease that is evaluated to impact live expectancy beyond the duration of the study follow-up (3 years)
• Retinal detachment under silicone oil fill
• Patients with a silica gel allergy or scar diathesis
• Patients with serious heart, lung, liver, or kidney dysfunction
• Patients with proliferative diabetic retinopathy, endophthalmia, uveitis and other uncontrollable eye diseases, or a contralateral eye that had intraocular retinal surgery
• Patients with history of drug abuse or alcoholism
• Patients are had participating in other drug or medical device clinical trials before screening for this trial
• Pregnancy, preparation for pregnancy during clinical trial, or breast-feeding
• Belief by any of the research doctors that a patient's condition would hinder the clinical trial, such as a patient prone to mental stress, loss of control of mood, or depression

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven (UZLeuven)

Leuven, Vl-Brabant, B3000, Belgium

Location

Study Officials

• Peter Stalmans, MD Phd

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinic

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: January 4, 2018
• Study Start: May 2, 2017
• Primary Completion: May 2, 2020
• Study Completion: May 5, 2020
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)